Browsing Tag
U.S. FDA
22 posts
Lupin gets US FDA nod for generic Xarelto; Eyes $8bn anticoagulant market
Lupin wins FDA approval for generic Xarelto, unlocking access to a USD 8 billion U.S. anticoagulant market. Find out what this means for investors and rivals.
Lupin reports robust FY25 earnings with 71% profit growth and 600% dividend payout
Lupin posts 71% profit growth in FY25 with 600% dividend and strong U.S. performance. Find out how the pharma major is transforming its global footprint.
Medtronic’s next-generation Affera technologies strengthen innovation in atrial fibrillation care
Find out how Medtronic’s Affera™ system is redefining atrial fibrillation care with breakthrough pulsed field ablation technologies. Read the full update!
Biocon Biologics strengthens US market presence with Civica insulin deal
As insulin prices remain a pressing concern in the United States, Biocon Biologics collaboration with Civica, Inc. has…
ALK’s ODACTRA gains FDA approval for pediatric house dust mite allergy treatment
The U.S. Food and Drug Administration (FDA) has expanded the approved use of ODACTRA house dust mite allergy…
Wockhardt sees Q2 revenue surge, driven by antibiotic innovation and biosimilar expansion
Wockhardt Limited, a leading pharmaceutical and biotechnology company, released its second-quarter financial results for the fiscal year 2024-25,…
FDA grants FELIQS fast track status for FLQ-101 in ROP preventive treatment
FELIQS, a multinational clinical-stage biopharmaceutical firm headquartered in Japan, has announced that its leading asset, FLQ-101, has received…
Orthocell secures key regulatory approval for Remplir in Singapore, paving way for ASEAN expansion
Orthocell, an Australian regenerative medicine company, has achieved a significant milestone with the receipt of major international regulatory…
Miracle cure: Wockhardt’s experimental drug defeats deadly superbug in dramatic recovery
Wockhardt Limited announced that its investigational drug Zaynich (Zidebactam/Cefepime) has successfully treated a complex case of bacterial meningitis…
Galderma’s breakthrough drug Nemluvio gains rapid FDA approval for severe itch condition
Galderma has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving Nemluvio (nemolizumab) for…